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Quality control method for Chinese medicine composition preparation for treating children's cold

A quality control method and technology for children with colds, which can be used in drug combinations, anti-infective drugs, and pharmaceutical formulas, and can solve problems such as quality control of difficult preparations

Inactive Publication Date: 2007-03-28
张友生
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are some deficiencies in the current quality control method of Xiaoer Ganmaoning Granules, making it difficult to carry out more effective quality control of the preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0024] Experimental example 1 Assay research

[0025] 1. Instruments and reagents

[0026] SP8810 high-performance liquid chromatography: Spectra 100 ultraviolet detector; SP4270 integrator: SEPU3000P workstation: Unicam Uv530 ultraviolet-visible spectrophotometer; KQ-100 ultrasonic cleaner. Baicalin reference substance (715-200111 for content determination by China Institute for the Control of Pharmaceutical and Biological Products). Methanol: chromatographically pure: water: ultrapure water: other reagents: all analytically pure,

[0027] 2. High performance liquid chromatography conditions:

[0028] Ilypersil ODS2 (4.6×200mm, 5μm) stainless steel column; mobile phase: methanol-water-phosphoric acid (44:56:0.2); flow rate: 1.0ml / min; detection wave K: 280nm; column temperature: room temperature.

[0029] 3. Standard curve

[0030] Accurately weigh an appropriate amount of baicalin reference substance, add methanol to make solutions containing 30.4, 60.8, 91.2, 121.6, ...

Embodiment 1

[0072] Mint 80g Nepeta spike 67g Bitter almond 80g Burdock seed 80g

[0073] Scutellaria baicalensis 80g Bellflower 67g Peucedanum 80g Angelica dahurica 27g

[0074] Gardenia (fried) 40g Hawthorn (burned) 27g Liushenqu (burned) 27g Malt (burned) 27g

[0075] Reed root 120g Honeysuckle 120g Forsythia 80g

[0076] (Preparation method) The above fifteen flavors, except the volatile oil extracted from mint and nepeta ears, and the almond water prepared from bitter almonds, the other twelve flavors such as burdock seeds are boiled twice with water, the first time for 2 hours, and the second time for 1 hour , filter, combine the filtrate, let it stand for 48 hours, take the supernatant and concentrate it to a clear paste with a relative density of 1.30, add almond water, stir well, add an appropriate amount of sucrose, mix well, make granules, dry, and spray the above-mentioned volatile oil , mix well, pack into 100 bags, and get it.

[0077] Quality control method:

[0078] Ide...

Embodiment 2

[0082] Xiaoer Ganmaoning granule quality control method: (raw material composition and preparation method are the same as embodiment 1)

[0083] Identification:

[0084] a. Take 20g of this product, add 20ml of water to heat to dissolve, let it cool, add ethyl acetate to extract twice, 30ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml of absolute ethanol to dissolve the residue, and use it as the test sample solution. Take another baicalin reference substance, add methanol to make a solution containing 2mg per 1ml, as the reference substance solution. According to the thin-layer chromatography (Appendix VIB of the Chinese Pharmacopoeia 2000 edition), draw 3 μl of each of the above two solutions, and spot them on the same silica gel G thin-layer plate with carboxymethylcellulose sodium as the binder, and add ethyl acetate Ester-butanone-formic acid-water (6:3:1:1) was used as the developer, pre-balanced for 30 minutes, developed, taken out, dri...

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Abstract

The present invention discloses a quality control method of Chinese medicine composition for curing infantile common cold. Said method adopts thin-layer chromatography to identify active effective components of scutellaria root, arctium seed, gardenia fruit and forsythia fruit, and utilizes high-performance liquid determination method to determine the content of baicalin.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine composition preparation, in particular to a quality control method of a traditional Chinese medicine composition preparation for treating infantile colds. Background technique [0002] Because children's viscera are delicate, their spleen and stomach are weak, and they are susceptible to wind pathogens, children's cold is one of the most common exogenous diseases in infants and young children. It can occur all year round, especially in winter, spring, and autumn. After the onset, it is easy to affect the digestion and absorption functions of the spleen and stomach, and stop eating and stopping milk. The clinical manifestations of this disease are fever and chills, cough, runny nose, sneezing, etc. as the main symptoms. Xiaoer Ganmaoning Granules have a good effect on the treatment of this disease. Honeysuckle and forsythia are mainly used to disperse wind-heat from the ...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61P31/00A61P11/00A61P29/00G01N30/02
Inventor 张友生张思宁
Owner 张友生
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